Device for injecting a substance into an interlayer of a body tissue or organ

Abstract

Provided is a device for injection into an interlayer of an organ of a subject. The device includes a needle having a size transitional portion terminating in a sharp needle distal tip. The device also includes an elongated tissue separator that is shiftable in the needle lumen. An actuator shifts the tissue separator in the needle lumen between a first position, in which the separator distal tip is fixedly positioned proximally to the needle distal tip, and a second position in which the separator distal tip is fixedly positioned a predetermined distance distally from the needle distal tip.

What is claimed is: 
     
         1 . A device for injection into an interlayer of an organ of a subject, the device comprising:
 a needle comprising a needle lumen extending between a needle proximal end and a needle distal end, said needle distal end including a size transitional portion terminating in a sharp needle distal tip;   an elongated tissue separator having a separator distal tip, at least a portion of said elongated tissue separator being shiftable in the needle lumen; and   an actuator configured to shift said elongated tissue separator in said needle lumen between a first position, wherein said separator distal tip is fixedly positioned proximally to said needle distal tip, and a second position, wherein said separator distal tip is fixedly positioned a first predetermined distance distally from said needle distal tip; and   a cannula fluidly connectable between a syringe and said needle lumen, so that a fluid injected from said syringe is directly flowable to said needle distal tip via said cannula and said needle lumen.   
     
     
         2 . The device according to  claim 1 , wherein when said separator distal tip is in said first position, said separator distal tip protrudes from a laterally uncovered section of said size transitional portion. 
     
     
         3 . The device according to  claim 1 , wherein said elongated tissue separator has any one or more of the following features:
 a. said elongated tissue separator includes said cannula and an elongated probe comprising a probe fixed portion connected to an inner cannula wall of said cannula and a probe protruding portion extending distally from a cannula distal end of said cannula and terminating in said separator distal tip;   b. said elongated tissue separator is configured to allow flow of a fluid from said cannula to said needle lumen around said probe fixed portion;   c. the cannula is provided with a seal configured to allow sliding of said elongated tissue separator therealong;   d. the cannula is provided with said seal configured to allow sliding of said elongated tissue separator therealong and said cannula distal end is positioned within or distally to, said seal when said separator distal tip is fixedly positioned proximally to said needle distal tip and fixedly positioned the first predetermined distance distally from said needle distal tip.   
     
     
         4 . The device according to  claim 1 , wherein said syringe is connectable to a separator hub of said elongated tissue separator. 
     
     
         5 . The device according to  claim 1 , further comprising an external stopper provided externally to said needle and configured to prevent penetration of said needle distal tip in the organ beyond a second predetermined distance. 
     
     
         6 . The device according to  claim 5 , wherein said external stopper has any one or more of the following features:
 a. said external stopper is a tube extending along said needle with a stopper distal end thereof located proximally to said needle distal tip by said second predetermined distance; and   b. said external stopper is a tube extending along said needle with said stopper distal end thereof located proximally to said needle distal tip by said second predetermined distance and said stopper distal end is fixedly positioned, or selectively shiftable along said needle, proximally to said size transitional portion.   
     
     
         7 . The device according to  claim 1 , wherein said actuator comprises a switch, the switch being switchable between two or more switch modes for shifting the actuator between fixed positions of the actuator. 
     
     
         8 . The device according to  claim 1  further comprising an organ docking device for fixating a target tissue portion of the organ and directing needle penetration into the target tissue portion, the organ docking device comprising:
 an organ docking device body comprising an organ contact surface, configured to conform to a surface of the target tissue portion, and a needle directing surface configured to guide the needle in a penetration path through said organ contact surface; 
 an anchoring member configured to anchor the organ docking device to said target tissue portion; and 
 an anchoring actuator configured to shift said anchoring member between a withdrawn position, wherein said anchoring member is prevented from physically interacting with the target tissue portion when in contact with said organ contact surface, and an anchoring position, wherein said anchoring member anchors to said target tissue portion so as to generate counteracting forces between said organ docking device body and the organ during penetration into the target tissue portion with said needle along said penetration path. 
 
     
     
         9 . The device according to  claim 8 , wherein said anchoring member has any one or more of the following properties:
 a. said anchoring member comprises at least one anchor connected to said organ docking device body, the at least one anchor being provided with a sharp anchor tip for penetrating into said target tissue portion;   b. when the anchoring member is in said withdrawn position, said anchor tip is positioned proximally to said organ contact surface, and when the anchoring member is in said anchoring position, said anchor tip is positioned distally to said organ contact surface for anchoring to the target tissue portion; and   c. when the anchoring member is in said anchoring position, said at least one anchor is directed from a peripheral point towards an opposing peripheral point, around said organ contact surface.   
     
     
         10 . The device according to  claim 8 , further comprising a tissue pressing member configured for pressing against said target tissue portion when in contact with said organ contact surface. 
     
     
         11 . The device according to  claim 8 , wherein said needle directing surface is tiltable relative to the organ docking device. 
     
     
         12 . The device according to  claim 8 , wherein said anchoring member includes a first anchor and a second anchor. 
     
     
         13 . The device according to  claim 12 , wherein said needle-penetration path passes between said first anchor and said second anchors. 
     
     
         14 . The device according to  claim 12 , wherein each one of said first anchor and said second anchor includes an anchor size transitional portion ending with said an anchor distal tip and a slender restrictor with a blunt restrictor tip thereof fixedly positioned between ends of said anchor size transitional portion and is protruding from a laterally uncovered section of said anchor size transitional portion. 
     
     
         15 . The device according to  claim 8 , wherein said anchoring actuator comprises an anchoring trigger configured to cause at least one anchor to shift between said withdrawn position and said anchoring position. 
     
     
         16 . The device according to  claim 1 , wherein the interlayer of the organ of the subject comprises a suprachoroidal space of an eye of the subject, and said fluid comprises a therapeutic composition comprising viscous agents for a short term buckling effect or a long term buckling effect. 
     
     
         17 . A method for injection of a substance or object into an interlayer region in an eye of a subject, the method comprising:
 a. providing a device for injection into an interlayer of an organ of the subject, the device comprising:   a needle comprising a needle lumen extending between a needle proximal end and a needle distal end, said needle distal end including a size transitional portion terminating in a sharp needle distal tip;   an elongated tissue separator having a separator distal tip, at least a portion of said elongated tissue separator being shiftable in the needle lumen; and   an actuator configured to shift said elongated tissue separator in said needle lumen between a first position, wherein said separator distal tip is fixedly positioned proximally to said needle distal tip, and a second position, wherein said separator distal tip is fixedly positioned a first predetermined distance distally from said needle distal tip;   b. positioning said separator distal tip at the first position between ends of said size transitional portion,   c. positioning said separator distal tip at a first predetermined distance proximally to said needle distal tip, the separator distal tip protruding from the size transitional portion;   d. penetrating an outer surface of the organ at a penetration point into the organ using said needle distal tip until contacting an organ outer surface layer with said separator distal tip, wherein said first predetermined distance distally from said needle distal tip is shorter than a thickness of said organ outer surface layer adjacent to said penetration point; and   e. injecting said substance or object into the interlayer of the organ.   
     
     
         18 . The method according to  claim 17  further comprising using said actuator to shift said elongated tissue separator longitudinally in said needle lumen such that said separator distal tip is repositioned to a distal-most position, wherein said separator distal tip is located a second predetermined distance distally to said needle distal tip, thereby advancing in said organ outer surface layer and penetrating through said organ outer surface layer into the interlayer of the organ and forming a passage in said interlayer of the organ with said separator distal tip. 
     
     
         19 . The method according to  claim 17 , comprising creating a directional space in the interlayer region, and filling the directional space with fluid which then disperses throughout the interlayer region.